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FDA Sends Mass Warnings, Seeks to End 1997 Drug Ad Rule After White House Directive

Legal, logistical hurdles could delay implementation for years.

Overview

  • President Trump issued a memorandum directing the FDA and other agencies to step up enforcement against misleading direct-to-consumer prescription drug promotions on TV, websites and social media.
  • The FDA says it has dispatched thousands of warning letters and roughly 100 cease‑and‑desist notices, including a general form letter instructing companies to bring all promotional communications into compliance.
  • The agency has opened rulemaking to eliminate the 1997 “adequate provision” approach, moving toward fuller on‑air risk disclosures instead of directing viewers to separate sources for complete safety information.
  • Officials say enforcement will extend beyond broadcast to close digital gaps by targeting influencer partnerships, sponsored content, algorithm‑targeted and AI‑generated promotions, telehealth marketers and online pharmacies.
  • Legal experts flag First Amendment challenges, prior court setbacks and recent staffing cuts that could slow or narrow enforcement, and analysts warn broadcasters could lose billions in pharma ad revenue if TV spots become impractical.